Download Taller de bioética - Instituto Oncológico Henry Moore

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de Medicina de Tucumán.
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Por favor háganos saber su crítica,
es la única manera que conocemos para mejorar y superarnos.
Gracias.
Prof. Ernesto Gil Deza
Prof. Felipe Gustavo Gercovich
Taller de bioética
Maestría médica
Facultad de Medicina
Universidad Nacional de Tucumán
Ernesto Gil Deza
Felipe Gustavo Gercovich
Objetivo del taller
• “… the goal of teaching ethics to health
care practitioners is not only to convey
information about available moral theories
but also to cultivate moral sensitivity in
practical situations …”
Suzanne M. Jaeger PhD
Teaching health care ethics: the importance of moral sensitivity for moral
reasoning
Nursing Philosophy
Volume 2 Issue 2 Page 131 - July 2001
Condiciones
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Libertad
Participación
Comunicación
Respeto
Honestidad
Por eso predicamos con el
ejemplo
• Libre consentimiento de participación
Seguimos con el conocimiento
mutuo
• Lea cuidadosamente el instructivo y llene la
siguiente ficha.
Mientras tanto me presento yo…
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43 años (04 de Agosto de 1959)
Casado
3 hijos
Cátedra de Oncología en Postgrado USAL
Recibido en 1984 (Fac. Medicina UNT)
Promedio general de la carrera: 9.72
Idioma inglés: nivel b (lee y escribe)
Bioética: nivel b (análisis de casos )
Bioética
 Aspectos generales e investigaciones con
seres humanos
 Cuidado del paciente muriente
 Etica de la prescripción médica
http//cme.nci.nih.gov/
Taller de bioética
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Costumbre
Religión
Moral
Ética
Ley
Norma
Guía
Taller de bioética
• Costumbre – Modo/moda - Hábito
• Religión: preformal – formal – institucional
- informal
• Moral
• Etica
• Ley
• Norma
• Guía
Taller de bioética
• Costumbre
• Religión
• Moral (arte) y práctica de las buenas costumbres –
seculares o religiosas
• Etica (ciencia) y teoría de los fundamentos y
razones de las conductas deseables
• Ley:
• Norma
• Guía
Taller de bioética
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Costumbre
Religión
Moral
Etica
Ley: mínimo de moral exigible
Norma: conducta impuesta
Guía: conducta sugerida
Filosofía moral vs. ética
• El objeto de la filosofía moral son las
actividades humanas orientadas a un fin,
teniendo en cuenta que el hombre actúe en
forma voluntaria y libre.
• Hombre: Inteligencia (abstracta) y Voluntad
(libre) libre
– Coerciones
– Coacciones
Filosofía moral vs. ética
• La ética: descriptiva, analítica y de la
ciencia, procura emplear el método
científico y los conocimientos científicos
del individuo y la sociedad para definir una
conducta deseable.
P (x,x’/RUCD)
Mario Bunge Etica, Ciencia y Técnica
Etica médica
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Hipócrates
Platón
Tomás de Aquino
Descartes
Kant
Freud
Beauchamp
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Secular
Utilitarista
Virtuosa (Benef)
Respetuosa (Aut.)
Equitativa (Just)
Abierta
Transdisciplinaria
Historia de un esfuerzo por
mejorar
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Hipócrates y “primero no dañar”
Celso y su oposición a la “vivisección”
1830 en Inglaterra ley del consentimiento
1865 Claude Bernard “Principios de moralidad para
clínicos y cirujanos” – No experimentar cuando puede
esperarse daño aunque sea interesante.
• 1900 Prusia: no experimentar en minusválidos ni
incompetentes.
• 1910 Paul Ehrlich: fármacoterapia igual responsabilidad
que cirugía.
• 1931 Alemania “Guias para terapias innovativas y
experimentación científica”
Bioética 1
• Evidencia de un comportamiento médico
cuestionable
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Investigaciones clínicas
Torturas
Pena de muerte
Prisiones
Manicomios
Minorías étnicas
Investigaciones Nazis
 Inyectar gasolina intravenosa
 Inyectar virus vivos
 Mantener cepas de tifus usando como
medios de cultivos prisioneros
 Inmersión en agua helada
 Prueba del paracaidista
 Ulceras cutáneas con fósforo
NUREMBERG
EL JUICIO A LOS MEDICOS
Los Jueces
Los fiscales
NUREMBERG
EL JUICIO A LOS MEDICOS
Los acusados
Los experimentos
Código de Nuremberg
1945
NUREMBERG CODE
The duty and responsibility for ascertaining the quality of the consent
rests upon each individual who initiates, directs or engages in the
experiment. It is a personal duty and responsibility which may not
be delegated to another with impunity.
1.The voluntary consent of the human subject is absolutely
essential. This means that the person involved should have legal
capacity to give consent; should be so situated as to be able to exercise
free power of choice, without the intervention of any element of force,
fraud, deceit, duress, over-reaching, or other ulterior form of constraint
or coercion; and should have sufficient knowledge and comprehension
of the elements of the subject matter involved as to enable him to make
an understanding and enlightened decision. This latter element requires
that before the acceptance of an affirmative decision by the experimental
subject there should be made known to him the nature, duration,
and purpose of the experiment; the method and means by which it is
to be conducted; all inconveniences and hazards reasonable to be
expected; and the effects upon his health or person which may possibly
come from his participation in the experiment.
2
The experiment should be such as to yield fruitful results for the
good of society, unprocurable by other methods or means of
study, and not random and unnecessary in nature.
3
The experiment should be so designed and based on the
results of animal experimentation and a knowledge of the
natural history of the disease or other problem under study that
the anticipated results will justify the performance of the
experiment.
4
The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
5
No experiment should be conducted where there is an a
priori reason to believe that death or disabling injury will
occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects.
6.The degree of risk to be taken should never exceed that determined by
the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to
protect the experimental subject against even remote possibilities of injury,
disability, or death.
8. The experiment should be conducted only by scientifically qualified
persons. The highest degree of skill and care should be required through all
stages of the experiment of those who conduct or engage in the
experiment.
9. During the course of the experiment the human subject should be at
liberty to bring the experiment to an end if he has reached the physical or
mental state where continuation of the experiment seems to him to be
impossible.
10. During the course of the experiment the scientist in charge must be
prepared to terminate the experiment at any stage, if he has probable
cause to believe, in the exercise of the good faith, superior skill and careful
judgment required of him that a continuation of the experiment is likely to
result in injury, disability, or death to the experimental subject.
Tuskegee 1939 - 1975
Taliaferro, Clark
¿ Qué tienen en común todos ellos ?
Estudio Tuskegee
• Alabama
• 400 varones de raza negra afectados por
sífilis y 200 controles.
• Engañados para el seguimiento sin
tratamiento – bad blood• 1932 – 1972 a pesar de evidencias desde
1942 de que el grupo con sífilis
evolucionaba peor que el control y que
desde 1940 estaba disponible la penicilina
UNIDAD 731
JAPON
Ishii Shiro
Cirugía sin anestesia
Vivisección de una joven
embarazada
Torre en memoria de los muertos
en la unidad 731
Fisiología de Hierro y Calcio
MIT y Harvard University
1949
Estudio con iones radioactivos
Fe - Ca
Jewish Chronical Disease
Hospital Study
Nueva York
1963
Jewish Chronic Disease Hospital
Study
• Rechazo de células cancerosas
• Pacientes “sanos” debilitados
• No se explicó el estudio para no generar
miedo.
• Se consideró que no había riesgo porque los
sanos rechazarían las células
Willowbrook Study
Nueva York
1963
DESARROLLO DE LA ETICA
MEDICA
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De la deontología a la bioética.
Empirismo
Utilitarismo
Kantianismo: deber ser
Etica de principios
Etica de valores
PRINCIPIOS BIOETICOS
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No maleficencia
Beneficencia
Autonomía
Justicia
The Belmont Report
Office of the Secretary
Ethical Principles and Guidelines for the Protection of
Human
Subjects of Research
The National Commission for the Protection of Human
Subjects
of Biomedical and Behavioral Research
April 18, 1979
Members of the Commission
Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women.
Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University.
Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
Dorothy I. Height, President, National Council of Negro Women, Inc.
Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at
San Francisco.
Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.
Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of
Religion.
*** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine,
University of Texas at Dallas.
***Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological
Psychology, University of Pennsylvania.
*** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle,
Washington, D.C.
*** Deceased.
1. Respect for Persons. -- Respect for persons incorporates
at least two ethical convictions: first, that individuals should
be treated as autonomous agents, and second, that persons
with diminished autonomy are entitled to protection. The
principle of respect for persons thus divides into two
separate moral requirements: the requirement to
acknowledge autonomy and the requirement to protect
those with diminished autonomy.
An autonomous person is an individual capable of
deliberation about personal goals and of acting under the
direction of such deliberation. To respect autonomy is to
give weight to autonomous persons' considered opinions
and choices while refraining from obstructing their actions
unless they are clearly detrimental to others. To show lack
of respect for an autonomous agent is to repudiate that
person's considered judgments, to deny an individual the
freedom to act on those considered judgments, or to
withhold information necessary to make a considered
judgment, when there are no compelling reasons to do so.
In most cases of research involving human subjects,
respect for persons demands that subjects enter into the
research voluntarily and with adequate information.
2. Beneficence. -- Persons are treated in an ethical manner
not only by respecting their decisions and protecting them
from harm, but also by making efforts to secure their wellbeing. Such treatment falls under the principle of
beneficence. The term "beneficence" is often understood to
cover acts of kindness or charity that go beyond strict
obligation. In this document, beneficence is understood in a
stronger sense, as an obligation. Two general rules have
been formulated as complementary expressions of
beneficent actions in this sense: (1) do not harm and (2)
maximize possible benefits and minimize possible harms.
3. Justice. -- Who ought to receive the benefits of research
and bear its burdens? This is a question of justice, in the
sense of "fairness in distribution" or "what is deserved." An
injustice occurs when some benefit to which a person is
entitled is denied without good reason or when some burden
is imposed unduly. Another way of conceiving the principle
of justice is that equals ought to be treated equally.
There are several widely accepted formulations of just ways
to distribute burdens and benefits. Each formulation
mentions some relevant property on the basis of which
burdens and benefits should be distributed. These
formulations are
(1) to each person an equal share,
(2) to each person according to individual need,
(3) to each person according to individual effort,
(4) to each person according to societal contribution, and
(5) to each person according to merit.
Questions of justice have long been associated with social
practices such as punishment, taxation and political representation.
Until recently these questions have not generally been associated
with scientific research. However, they are foreshadowed even in
the earliest reflections on the ethics of research involving human
subjects. For example, during the 19th and early 20th centuries the
burdens of serving as research subjects fell largely upon poor ward
patients, while the benefits of improved medical care flowed
primarily to private patients. Subsequently, the exploitation of
unwilling prisoners as research subjects in Nazi concentration
camps was condemned as a particularly flagrant injustice. In this
country, in the 1940's, the Tuskegee syphilis study used
disadvantaged, rural black men to study the untreated course of a
disease that is by no means confined to that population. These
subjects were deprived of demonstrably effective treatment in
order not to interrupt the project, long after such treatment became
generally available.
1. Informed Consent.
2. Assessment of Risks and Benefits
3. Selection of Subjects
Primer muerte por terapia génica
Declaración de Helsinki
1964 - 2000
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
.pdf
The Helsinki Declaration in Norwegian.
Ethical Principles for Medical Research Involving Human
Subjects
Adopted by the 18th WMA General Assembly
Helsinki, Finland, June 1964
and amended by the
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South
Africa, October 1996
and the
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
A. INTRODUCTION
1.
The World Medical Association has developed the Declaration of
Helsinki as a statement of ethical principles to provide guidance
to physicians and other participants in medical research involving
human subjects. Medical research involving human subjects
includes research on identifiable human material or
identifiable data.
2.
It is the duty of the physician to promote and safeguard the
health of the people. The physician's knowledge and
conscience are dedicated to the fulfillment of this duty.
7.
In current medical practice and in medical research, most prophylactic,
diagnostic and therapeutic procedures involve risks and burdens.
8.
Medical research is subject to ethical standards that promote respect
for all human beings and protect their health and rights. Some
research populations are vulnerable and need special protection. The
particular needs of the economically and medically disadvantaged must be
recognized. Special attention is also required for those who cannot give or
refuse consent for themselves, for those who may be subject to giving
consent under duress, for those who will not benefit personally from the
research and for those for whom the research is combined with care.
9.
Research Investigators should be aware of the ethical, legal and regulatory
requirements for research on human subjects in their own countries as
well as applicable international requirements. No national ethical, legal
or regulatory requirement should be allowed to reduce or eliminate any of
the protections for human subjects set forth in this Declaration.
10.
It is the duty of the physician in
medical research to protect
•the life,
•health,
•privacy, and
•dignity of the human subject.
12.
Appropriate caution must be exercised in the
conduct of research which may affect the
environment, and the welfare of animals
used for research must be respected.
13.
The design and performance of each experimental procedure
involving human subjects should be clearly formulated in an
experimental protocol. This protocol should be submitted for
consideration, comment, guidance, and where appropriate, approval
to a specially appointed ethical review committee, which must be
independent of the investigator, the sponsor or any other kind of
undue influence. This independent committee should be in
conformity with the laws and regulations of the country in which the
research experiment is performed. The committee has the right to
monitor ongoing trials. The researcher has the obligation to provide
monitoring information to the committee, especially any serious
adverse events. The researcher should also submit to the
committee, for review, information regarding funding, sponsors,
institutional affiliations, other potential conflicts of interest and
incentives for subjects.
19. Medical research is only justified if there is a
reasonable likelihood that the populations in which the
research is carried out stand to benefit from the results
of the research.
20. The subjects must be volunteers and informed
participants in the research project.
21. The right of research subjects to safeguard their
integrity must always be respected. Every precaution
should be taken to respect the privacy of the subject,
the confidentiality of the patient's information and to
minimize the impact of the study on the subject's
physical and mental integrity and on the personality of
the subject.
22. In any research on human beings, each potential subject must
be adequately informed of the aims, methods, sources of funding,
any possible conflicts of interest, institutional affiliations of the
researcher, the anticipated benefits and potential risks of the study
and the discomfort it may entail. The subject should be informed of
the right to abstain from participation in the study or to withdraw
consent to participate at any time without reprisal. After ensuring
that the subject has understood the information, the physician
should then obtain the subject's freely-given informed consent,
preferably in writing. If the consent cannot be obtained in writing, the
non-written consent must be formally documented and witnessed.
23.When obtaining informed consent for the research project the
physician should be particularly cautious if the subject is in a
dependent relationship with the physician or may consent under
duress. In that case the informed consent should be obtained by a
well-informed physician who is not engaged in the investigation and
who is completely independent of this relationship.
27. Both authors and publishers have ethical
obligations. In publication of the results of research,
the investigators are obliged to preserve the accuracy
of the results. Negative as well as positive results
should be published or otherwise publicly available.
Sources of funding, institutional affiliations and any
possible conflicts of interest should be declared in the
publication. Reports of experimentation not in
accordance with the principles laid down in this
Declaration should not be accepted for publication.
29. The benefits, risks, burdens and effectiveness of
a new method should be tested against those of the
best current prophylactic, diagnostic, and
therapeutic methods. This does not exclude the use
of placebo, or no treatment, in studies where no
proven prophylactic, diagnostic or therapeutic
method exists.
CODE OF FEDERAL REGULATIONS
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
PART 46
PROTECTION OF HUMAN SUBJECTS
***
Revised November 13, 2001
Effective December 13, 2001
REQUISITOS ETICOS DE LAS
INVESTIGACIONES CLINICAS
Pacto Internacional de Derechos Civiles y Políticos
Art 7: Nadie será sometido a torturas ni a
penas o tratos crueles, inhumanos o
degradantes.
REQUISITOS ETICOS DE LAS
INVESTIGACIONES CLINICAS
Pacto Internacional de Derechos Civiles y Políticos
Constitución de la Nación Argentina - 1994
Art 7: Nadie será sometido a torturas ni a
penas o tratos crueles, inhumanos o
degradantes. En particular nadie será
sometido sin su libre consentimiento a
experimentos médicos o científicos.
REQUISITOS ETICOS DE LAS
INVESTIGACIONES CLINICAS
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5330/97
IGNORANCIA DE RESULTADO
PROTOCOLO ESCRITO
OBJETIVOS CLAROS
NUMERO SUFICIENTE DE PACIENTES
CONSENTIMIENTO INFORMADO
SELECCIÓN DE INVESTIGADORES
REVISION POR COMITÉ DE ETICA
INFORMACION DE EFECTOS ADVERSOS SEVEROS
SEGURO DE INVESTIGACION
REQUISITOS ETICOS DE LAS
INVESTIGACIONES CLINICAS
CONSENTIMIENTO INFORMADO
• COMPLETO
• CLARO
• PUNTOS INSOSLAYABLES:
• CARÁCTER INVESTIGACIONAL
• LIBRE ACEPTACION
• NO IMPACTO EN RELACION MEDICO-PACIENTE.
• FIRMADO EN PRESENCIA DE UN TESTIGO
FASES DE INVESTIGACION
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FASE 0 = PRECLINICA
FASE I = TOLERANCIA (DMT - TDL)
FASE II = RESPUESTA
FASE III = COMPARACION CON STANDARD
FASE IV = FARMACOVIGILANCIA
EL PROBLEMA DE LAS INVESTIGACIONES QUE NO
SIGUEN ESTE DESARROLLO ES LA FALTA DE
RESPETO POR LA PERSONA ENFERMA Y EL
RETRASO DE LAS INVESTIGACIONES
Bioética y Sociedad
• Evidencias de un comportamiento humano
cuestionable
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–
–
–
–
Derechos políticos (Rev. Francesa – Americana)
Derechos humanos (Post guerras mundiales S.XX)
Liberación femenina (“Pill revolution”)
Liberación existencial (Hippies)
Ecología (“Green Revolution)
• 1971 - Van Rensselaer Potter (oncólogo):
Bioethics: bridge to the future
– Puente entre la ciencia de la vida y la ética de la vida.
– “Los valores éticos no pueden separarse de los hechos
biológicos”
– “La ciencia sin conciencia no conduce sino a la ruina
del hombre”
– Hacer ética no es un quehacer sólo de filósofos sino
que pasa a ser un deber y un derecho de todo hombre.
• Jacques Testart (“padre” de Amande la primer niña
probeta francesa en 1982)
– 1987: “Yo, Jacques Testart, investigador en el campo de
la biogenética, he decidido acabar definitivamente con
la carrera enloquecida hacia la novedad científica; no
quiero ir más lejos. Abandono por razones éticas ciertos
campos de la investigación. Es preciso un control sobre
las técnicas humanas de la procreación”. (Gonzalo
Higueras - ¿Prudencia o miedo? – Razón y Fe, Marzo
de 1987, pag 315
Dilemas éticos
en
Revistas médicas
Transdiciplinaridad
Dilemas clásicos
Metodología
Adaptación
Medicación OTC ...y de las otras
Confidencialidad
Equidad
Justicia
Relaciones institucionales
Credibilidad 1
Credibilidad 2
Desafíos de las noticias 1
Clarin
8 de Febrero de 2002
Conflictos de intereses 1
JAMA 7 de Febrero 2002
Conflictos de intereses 1
Clarin 8 de Febrero de 2002
Conflictos de intereses 2
Desafíos de las noticias 2
Clarin
28 de Febrero de 2002
Clonación para transplante
Una lucha global contra este técnica
SEMIOLOGIA DE UN DILEMA
ETICO
• Definición del problema (Motivo de
consulta)
– Conflicto de valores (fines o medios)
• Concepto de valor
• Axiología
– Conflicto de comunicación (incomprensión)
• Comunicación
• Información
– Conflicto de intereses (beneficios)
SEMIOLOGIA DE UN DILEMA
ETICO
• Historia y significación (Enfermedad actual)
– Cronología (secuencia temporal)
• Percepción
• Emociones
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–
–
–
Causalidad (secuencia interpretativa)
Condicionantes (Five W : Who-What-When-Where-Why)
Requerimiento
Participantes
SEMIOLOGIA DE UN DILEMA
ETICO
• Contrastación (Examen Físico)
– Entrevista con el Requerido
• Cronología (secuencia temporal)
– Percepción
– Emociones
• Causalidad (secuencia interpretativa)
• Condicionantes
– Evaluación de Historia Clínica y/o Documentos
– Evaluación de lugar
Terapéutica de un dilema ético
• Resolución arbitral
• Mediación
• Comité multidisciplinario
– Hospitalario (institucional)
– De investigaciones clínicas
• Justicia
Prevención de conflictos éticos
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Idoneidad
Consistencia
Coherencia
Respeto
Honestidad
Humildad
Veracidad
Tolerancia
Prevención de mala praxis
• Prevención de conflictos éticos
• Registro completo
Bioética
Aspectos generales e investigaciones
con seres humanos
Cuidado del paciente muriente
Etica de la prescripción médica